Arbutus Biopharma Corporation (Nasdaq: ABUS) and Vaccitech plc
(Nasdaq: VACC) today announced that the companies have entered into
a clinical trial collaboration agreement to evaluate an innovative
therapeutic combination for the treatment of subjects with chronic
hepatitis B virus (HBV) infection (CHB) who are
already receiving standard-of-care nucleos(t)ide reverse
transcriptase inhibitor (NrtI) therapy.
The multi-center, Phase 2a clinical trial will
evaluate the safety, pharmacokinetics, immunogenicity, and
antiviral activity of Arbutus’s proprietary GalNAc delivered RNAi
therapeutic, AB-729, followed by Vaccitech’s proprietary
immunotherapeutic, VTP-300, in NrtI-suppressed subjects with CHB.
The Phase 2a clinical trial is expected to initiate in the second
half of this year and will be managed by Arbutus, subject to
oversight by a joint development committee comprised of
representatives from Arbutus and Vaccitech. The parties retain full
rights to their respective product candidates and will split all
costs associated with the clinical trial. Pursuant to the
agreement, the parties intend to undertake a larger Phase 2b
clinical trial depending on the results of the initial Phase 2a
clinical trial.
“Based on the positive clinical results we have
seen in our ongoing Phase 1a/1b clinical trial for AB-729,
including recent data demonstrating increased
HBV-specific immune responses, we believe AB-729 has the potential
to become a cornerstone therapeutic in multiple future HBV
combination regimens,” stated Gaston Picchio, Chief Development
Officer at Arbutus. “We are looking forward to initiating this
proof-of-concept Phase 2a clinical trial, which will allow us to
evaluate the combination of two promising clinical candidates with
potential complimentary mechanisms of action. We believe combining
AB-729, which is designed to reduce HBsAg resulting in increased
HBV immune responses with VTP-300, an immunotherapeutic designed to
elicit an HBV specific immune response, may offer patients with CHB
a much needed and durable functional cure.”
“CHB is characterized by T cell exhaustion,
driven primarily by HBsAg, that may require immune modulation,”
said Tom Evans, MD, Vaccitech’s Chief Scientific Officer. “Current
treatments can control viral replication but do not cure the
disease. We believe that a combination of immunotherapy, such as
VTP-300, with agents that reduce hepatitis B surface antigen is a
promising approach toward a functional cure. This clinical trial
will be evaluating that hypothesis. If successful, we believe that
VTP-300, along with siRNA, such as AB-729, could be a foundation
for CHB combination therapy.”
About the Phase 2a Clinical Trial
Pending regulatory approval, the trial is
expected to enroll 40 NrtI-suppressed, Hepatitis B e-antigen
negative or positive, non-cirrhotic CHB subjects. Subjects are
expected to receive AB-729 + NrtI for 24 weeks. At Week 24,
subjects will be randomized 1:1 to receive either NrtI + VTP-300 or
NrtI + VTP-300 sham. At Week 48, all subjects are expected to be
evaluated for eligibility to either discontinue all treatments or
remain on their NrtI only. Subjects are expected to be followed for
an additional 48 weeks.
About AB-729
AB-729 is an RNA interference (RNAi) therapeutic
targeted to hepatocytes using Arbutus’ novel covalently conjugated
N-acetylgalactosamine (GalNAc) delivery technology that enables
subcutaneous delivery. AB-729 inhibits viral replication and
reduces all HBV antigens, including hepatitis B surface antigen in
preclinical models. Reducing hepatitis B surface antigen is thought
to be a key prerequisite to enable reawakening of a patient’s
immune system to respond to the virus. Based upon clinical data
generated thus far in an ongoing single- and multi-dose Phase 1a/1b
clinical trial, AB-729 has demonstrated positive safety and
tolerability data and meaningful reductions in hepatitis B surface
antigen.
About VTP-300
VTP-300 utilizes Vaccitech’s ChAdOx1-HBV/MVA-HBV
prime-boost combination to elicit an immune response against HBV.
The HBV DNA sequence contained in the viral vectors is derived from
a genotype C sequence, which is the most common genotype
circulating worldwide. Vaccitech’s proprietary platform has
demonstrated robust activation of cytotoxic CD8+ T cells (immune
cells associated with clearance of HBV infected cells), which are
believed to have the potential to lead to a functional cure for
patients with CHB, a life-threatening disease that affects more
than 250 million people worldwide. VTP-300 is currently being
evaluated in ongoing Phase 1/2a clinical trial in healthy
volunteers and CHB patients and a Phase 1b/2a clinical trial in CHB
patients in combination with a low-dose checkpoint inhibitor.
About HBV
Hepatitis B is a potentially life-threatening
liver infection caused by HBV. HBV can cause chronic infection
which leads to a higher risk of death from cirrhosis and liver
cancer. CHB represents a significant unmet medical need. The World
Health Organization estimates that over 250 million people
worldwide suffer from chronic HBV infection, while other estimates
indicate that approximately 2 million people in the United States
suffer from chronic HBV infection. Approximately 900,000 people die
every year from complications related to chronic HBV infection
despite the availability of effective prophylactic vaccines and
current treatment options.
About Arbutus
Arbutus Biopharma Corporation is a publicly
traded (Nasdaq: ABUS) biopharmaceutical company primarily focused
on discovering, developing and commercializing a cure for people
with chronic hepatitis B virus (HBV) infection. The Company is
advancing multiple product candidates with distinct mechanisms of
action that it believes have the potential to provide a new
curative regimen for chronic HBV infection. Arbutus has also
initiated a drug discovery and development effort for treating
coronaviruses (including COVID-19). For more information, visit
www.arbutusbio.com.
About Vaccitech
Vaccitech plc is a publicly traded (Nasdaq:
VACC) clinical-stage biopharmaceutical company engaged in the
discovery and development of novel immunotherapeutics and vaccines
for the treatment and prevention of infectious diseases and cancer.
The company’s proprietary platform comprises proprietary modified
simian adenoviral vectors, known as ChAdOx1 and ChAdOx2, as well as
the well-validated Modified Vaccinia Ankara, or MVA, boost vector,
both with demonstrable tolerability profiles and without the
ability to replicate in humans. The combination of a ChAdOx prime
treatment with subsequent MVA boost has consistently generated
significantly higher magnitudes of CD8+ T cells compared with other
technologies and approaches. The company has a broad pipeline of
both clinical and preclinical stage therapeutic programs in solid
tumors and viral infections and prophylactic viral vaccine
programs. Vaccitech co-invented a COVID-19 vaccine with the
University of Oxford, now approved for use in many territories and
exclusively licensed worldwide to AstraZeneca through Oxford
University Innovation, or OUI. Vaccitech is entitled to receive a
share of the milestones and royalty income received by OUI from
AstraZeneca.
Arbutus Forward-Looking Statements and
Information
This press release contains forward-looking
statements within the meaning of the Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of 1934,
and forward-looking information within the meaning of Canadian
securities laws (collectively, “forward-looking statements”).
Forward-looking statements in this press release include statements
about our expectations for the collaboration, including Arbutus’
belief that combining the ability of AB-729 to reduce HBsAg with
VTP-300, an immunotherapeutic that elicits an HBV specific immune
response, may offer patients with chronic hepatitis B a much needed
and durable functional cure; the timing and expected trial design
of the Phase 2a clinical trial to be initiated by the parties
pursuant to the agreement; Arbutus’ belief that AB-729 has the
potential to become a cornerstone therapeutic in multiple future
HBV combination regimens; and the parties’ plans for future
collaboration clinical trials depending on the results of the
initial Phase 2a clinical trial.
With respect to the forward-looking statements
contained in this press release, Arbutus has made numerous
assumptions regarding, among other things: the effectiveness and
timeliness of preclinical studies and clinical trials, and the
usefulness of the data; the timeliness of regulatory approvals; the
continued demand for Arbutus’ assets; and the stability of economic
and market conditions. While Arbutus considers these assumptions to
be reasonable, these assumptions are inherently subject to
significant business, economic, competitive, market and social
uncertainties and contingencies, including uncertainties and
contingencies related to the ongoing COVID-19 pandemic.
Additionally, there are known and unknown risk
factors which could cause Arbutus’ actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements contained herein. Known risk factors
include, among others: the parties may never realize the expected
benefits of the collaboration; anticipated clinical trials may be
more costly or take longer to complete than anticipated, and may
never be initiated or completed, or may not generate results that
warrant future development of the candidate; Arbutus may elect to
change its strategy regarding its product candidates and clinical
development activities; economic and market conditions may worsen;
market shifts may require a change in strategic focus; and the
ongoing COVID-19 pandemic could significantly disrupt clinical
development programs.
A more complete discussion of the risks and
uncertainties facing Arbutus appears in Arbutus’ Annual Report on
Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’
continuous and periodic disclosure filings, which are available
at www.sedar.com and at www.sec.gov. All
forward-looking statements herein are qualified in their entirety
by this cautionary statement, and Arbutus disclaims any obligation
to revise or update any such forward-looking statements or to
publicly announce the result of any revisions to any of the
forward-looking statements contained herein to reflect future
results, events or developments, except as required by law.
Vaccitech plc Forward-Looking Statement
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended, including, without limitation,
statements regarding risks and uncertainties related to Vaccitech’s
expectations regarding the benefits of this collaboration,
including the potential benefits of using VTP-300 in triple
combination with AB-729 and an NrtI, the timing and expected trial
design of the Phase 2a clinical trial to be initiated by the
parties pursuant to the agreement and Vaccitech’s expectations
that, if the clinical trial is successful, VTP-300 together with
AB-729, could be a foundation for CHB combination therapy. The
words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,”
“anticipate,” “intend,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue” and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Any
forward-looking statements in this press release are based on
management’s current expectations and beliefs and are subject to
numerous risks, uncertainties and important factors that may cause
actual events or results to differ materially from those expressed
or implied by any forward-looking statements contained in this
press release, including, without limitation, risks and
uncertainties related to timing and advancement of the planned
clinical trial and other risks identified in Vaccitech’s SEC
filings, including its Quarterly Report on Form 10-Q for the first
quarter of 2021 and subsequent filings with the SEC. Existing and
prospective investors are cautioned not to place undue reliance on
any forward-looking statements, which speak only as of the date
they are made. Vaccitech expressly disclaims any obligation to
publicly update or revise any such statements to reflect any change
in expectations or in events, conditions or circumstances on which
any such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the
forward-looking statements.
Arbutus Contact Information
Investors and Media
William H. CollierPresident and CEOPhone: 267-469-0914Email:
ir@arbutusbio.com
Pam MurphyInvestor Relations ConsultantPhone: 267-469-0914Email:
ir@arbutusbio.com
Vaccitech Contact Information
Investors:Vaccitech Investor
Relationsir@vaccitech.co.uk
Media: Katja Stout, Scius Communications
(EU)Direct: +44 (0)
7789435990Email: katja@sciuscommunications.com
Ryo Imai / Robert Flamm, Ph.D. (US), Burns McClellan,
Inc.212-213-0006 ext. 315 /
364Email: Rimai@burnsmc.com / rflamm@burnsmc.com
Henry Hodge,
VaccitechEmail: henry.hodge@vaccitech.co.uk
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